Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia

NCT07120555 | Not Yet Recruiting

• 1 other identifier: DFGCUOHBTR
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of amputation if left untreated. Infra-popliteal arteries are frequently involved in CLTI, especially in diabetic and elderly patients, posing significant challenges due to diffuse, calcified, and long-segment occlusive lesions. Conventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty alone remains controversial. Given the growing use of endovascular therapies, a comparative analysis of outcomes between combined atherectomy-balloon angioplasty and conventional angioplasty in infra-popliteal interventions is essential to guide evidence-based management in CLTI patients.

Conditions

Chronic Limb Threatening Ischemia

Outcome Measures

Primary Outcomes (1)

• • Compare the 12-month primary patency rate between the two groups.

  12 months

Study Arms (2)

atherectomy + balloon angioplasty

EXPERIMENTAL

Device: atherectomy

conventional balloon angioplasty

EXPERIMENTAL

Device: Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long

Interventions

atherectomy DEVICE

Conventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty alone remains controversial.

atherectomy + balloon angioplasty

Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long DEVICE

Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long

conventional balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients present with CLTI due to isolated infra-popliteal disease with the following criteria:
• Denovo or Recoil
• Reference tibial vessel diameter at least (2mm)
• The diseased tibial artery has a patent distal segment supplying the foot

You may not qualify if:

• Patients present with:
• Previous ipsilateral infrapopliteal bypass surgery
• Concomitant iliac or femoral artery lesion
• Isolated pedal arch disease
• previous atherectomy
• Faliure to cross the lesion
• Known hypercoagulable disorder or non-atherosclerotic vasculopathy
• Severe renal insufficiency (eGFR \<30) not on dialysis

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

ahmed moustafa hassan, assistant lecturer

CONTACT

00201149411028; amfa_2050@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 13, 2025
• Study Start: September 30, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08